The objective of the trial is to assess whether the combination of enoxaparine (LMWH) with progesterone increases the live birth rate compared to standard of care (no active treatment) in women with unexplained recurrent pregnancy loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Vaginal micronized progesterone 800 mg daily administered in two divided doses .
Administered subcutaneously once daily at a weight-adjusted prophylactic dose according to body weight or applicable local guidelines.
General University Hospital in Prague
Prague, Czechia
Live Birth Rate
Proportion of randomized participants who deliver at least one live-born infant at ≥24+0 weeks of gestation.
Time frame: At delivery (≥24+0 weeks of gestation)
Ongoing Pregnancy Rate at 22 Weeks
Proportion of randomized participants with an ongoing intrauterine pregnancy at 22+0 weeks of gestation, confirmed by ultrasound demonstrating fetal cardiac activity.
Time frame: From enrollment to the end of 22 weeks of the index pregnancy.
Maternal Complications
Incidence of pregnancy-related complications, including preeclampsia (defined by ISSHP), gestational hypertension, gestational diabetes, placental abruption, postpartum hemorrhage (defined as estimated blood loss \>500 mL following vaginal delivery or \>1000 mL following cesarean section).
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Neonatal Outcomes:
Birth weight (grams), APGAR scores at 1 and 5 minutes post-delivery (APGAR at 10 minutes may be recorded if available), admission to neonatal care unit (NICU), and presence of congenital anomalies confirmed postnatally.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Safety of the trial medication
Incidence of major bleeding events (overt bleeding requiring transfusion, surgical intervention, or hemodynamic intervention) and minor bleeding events (mucosal or injection-site bleeding), thrombocytopenia (defined as platelet count \<100,000/μL), hypersensivity, and injection-site reactions.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Adherence and Tolerability:
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Treatment discontinuation rate and reasons for discontinuation (including adverse events); participant-reported injection-site pain associated with LMWH treatment, assessed using a numerical rating scale from 0 (no pain) to 10 (worst imaginable pain); participant-reported missed doses of study treatment and reasons for missed doses; and completeness of medication diaries.
Time frame: Treatment discontinuation: from initiation at 5-7 weeks' gestation to 36+0 weeks or delivery. Pain and missed-dose outcomes: assessed at 20 and 34 weeks' gestation and 6 weeks postpartum.